Recall Z-2798-2016 ยท CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
Siemens Healthcare Diagnostics Inc
Siemens RAPIDPoint 405 Blood Gas Analyzer nBili Siemens Material Number (SMN): 10282093, 10310464, 10314817, 1031 7193, 10318999, 10320055, 10321238, 10322347, 10328278, 10328302, 10336784
| Date | Aug 11, 2016 |
| Status | Terminated |
| Reason | There is a potential for the first and/or last name of one patient to be printed with Patient ID and result data from a different patient, even though those fields have been turned Off for the system |
| Root cause | Software design |
| Action | Siemens Healthcare issued Urgent Field Safety Notice to (US) customers via Federal Express. . All affected customers outside the US provided a copy of an Urgent Field Safety Notice via hard copy, e-mail, and/or fax as determined by each countries local regulations and procedures. This notice informs customers of the issue, Actions to be Taken by the Customer and to return the response form. Questions contact your Siemens Customer Care Center or your local Siemens technical support representative |
| Quantity | 2910 units |
| Distribution | Nationwide Foreign: Albania Algeria Angola Argentina Armenia Australia Austria Bahrain Bangladesh Belarus Belgium Bosnia Herzeg. Botswana Brazil Brunei Bulgaria Canada Chile Colombia Croatia Czech Republic Denmark Ecuador Egypt Estonia Finland France Fren.Polynesia Georgia Germany Greece Hong Kong H |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K110277 | RAPIDPOINT 405 NEONATAL BILIRUBIN Siemens Healthcare Diagnostics, Aug 15, 2011 |